NCT06209723Recruiting
Vegetarian Diet and Innate Immunity in Patients With Myocardial Infarction and in Healthy Volunteers (FRESH-MI Study)
Effect of a Vegetarian Diet on Innate Immunity in Patients With Myocardial Infarction and in Healthy Volunteers (FRESH-MI Study)
Source: ClinicalTrials.gov · Last updated 14 Aug 2026
Brief summary (registry, in English)
The goal of this clinical trial is to assess the effect of a vegetarian diet on innate immunity of patients with a recent acute myocardial infarction and healthy participants. Also, we will assess the willingness to adapt a more vegetarian eating habit. Study subjects will follow a vegetarian diet for five weeks, whereafter a stabilisation period of six weeks will follow. Then, participants will follow to the other dietary intervention for five weeks. Blood will be drawn at given time points to analyse inflammatory parameters.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 10 Jul 2023
- Start date
- 26 Jan 2024
- Primary completion date
- 1 Sept 2027
- Lead sponsor
- Radboud University Medical Center
- Diseases
- Coronary artery disease
- NCT number
- NCT06209723
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 26 Jan 2024 to the primary completion date, 1 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous myocardial infarction
- Use of immunomodulatory drugs
- Vaccination less than one month before start of intervention
- Clinically significant infections within 1 months prior to start of intervention (defined as fever \>38.5 degrees Celsius)
- \- Use of lipid lowering therapy
Other illness
- Diabetes Mellitus
- Medical history of any disease associated with immune deficiency (either congenital or acquired, including chemotherapy, chronic steroid use, organ transplant)
- Active malignant haematological disease
- Known eating disorder (e.g., Anorexia nervosa, Bulimia nervosa)
Other
- Already on a vegetarian or vegan diet
Who the study is looking for
- Acute myocardial infarction (STEMI/NSTEMI) with a clear culprit lesion on angiography and successful primary percutaneous coronary intervention (PCI) \<1 week before randomisation
- Body mass index between 18.5 and 35 kg/m2
- Written informed consent
- Body mass index between 18.5 and 35 kg/m2
- Written informed consent
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Radboudumc Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.